MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	SONATA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
The user reported that the hearing performance has decreased.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device does not provide sufficient benefit due to a partial migration of the active electrode out of cochlea, which could be confirmed by diagnostic imaging.A re-insertion surgery is planned in (b)(6) 2022.
Event or Problem Description
The user reported that the hearing performance has decreased since the beginning of (b)(6) 2021.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device does not provide sufficient benefit due to a partial migration of the active electrode out of cochlea, which could be confirmed by diagnostic imaging.Reportedly the recipient was re-fitted and is doing better.
Event or Problem Description
The user reported that the hearing performance has decreased since the beginning on (b)(6) 2021.
Event or Problem Description
The user reported that the hearing performance has decreased since the beginning of (b)(6) 2021.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device did not provide sufficient benefit due to a partial migration of the active electrode out of cochlea, which could be confirmed by diagnostic imaging.A re-insertion surgery was performed successfully.The device remains implanted and in use.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 13223912
• Report Number: 9710014-2022-00025
• Device Sequence Number: 1463535
• Product Code: MCM
• UDI-Device Identifier: 09008737366148
• UDI-Public: (01)09008737366148
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/26/2023
• Device Model Number: SONATA
• Device Catalogue Number: 36614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022; 01/11/2022; 01/11/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/10/2022; 11/16/2022; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female